Gram-Positive Bacteria And Their Resistance Markers
The Gram-Positive Bacteria and Their Resistance Markers device is a qualitative multiplexed in vitro diagnostic device intended to detect and identify gram-positive bacteria and antibiotic resistance markers in positive blood cultures, enabling rapid identification of bloodstream pathogens. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is PAM, with regulation number 866.3365 under the Microbiology medical specialty.
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Basic Information
- Product Code
- PAM
- Device Class
- FDA class 2
- Regulation Number
- 866.3365
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay | Jun 06, 2025 | Substantially Equivalent | Luminex Corporation |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | Dec 20, 2018 | Substantially Equivalent | Genmark Diagnostics, Incorporated |
| K163390 | iC-GPC Assay TM for use on the iC-SystemTM | Aug 08, 2017 | Substantially Equivalent | Icubate, Inc. |
| K152470 | Great Basin Staph ID/R Blood Culture Panel | Mar 25, 2016 | Substantially Equivalent | Great Basin Scientific, Inc. |
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST | Sep 19, 2012 | Substantially Equivalent | Nanosphere, Inc. |
| DEN120014 | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) | Jun 26, 2012 | Unknown | Nanosphere, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.